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Trace Impurity Analysis

Trace Impurity Analysis

Trace impurity analysis is a specialized analytical technique used to detect, quantify, and characterize trace-level impurities and contaminants in materials, chemicals, and products. Trace impurities may include residual solvents, heavy metals, organic pollutants, and degradation products, which can affect product quality, performance, and safety. Analytical methods such as chromatography (e.g., gas chromatography, liquid chromatography), spectroscopy (e.g., atomic absorption spectroscopy, inductively coupled plasma mass spectrometry), and mass spectrometry are employed to analyze trace impurities accurately with high sensitivity and selectivity.
Accurate trace impurity analysis provides valuable information for quality control, regulatory compliance, and product safety in industries such as pharmaceuticals, chemicals, food and beverages, cosmetics, and environmental monitoring. In pharmaceutical manufacturing, it supports compliance with regulatory guidelines such as International Conference on Harmonization (ICH) guidelines for the control of residual solvents, impurities, and degradation products in drug substances and drug products. In environmental monitoring, it aids in assessing pollutant levels, identifying contamination sources, and evaluating exposure risks associated with trace-level impurities in air, water, soil, and biota. Moreover, trace impurity analysis plays a crucial role in materials characterization, forensic investigations, and product development by providing insights into material purity, stability, and compatibility.
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